Class 2 Device Recall Analogic

• Date Initiated by Firm: September 13, 2005
• Date Posted: October 12, 2005
• Recall Status: Terminated on August 07, 2006
• Recall Number: Z-0036-06
• Recall Event ID: 33337
• Product Classification: System, Monitoring, Perinatal - Product Code HGM
• Product: FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
• Code Information: Serial Numbers: FA002010 FA002051 FA002054 FA002059 FA002061 FA002062 FA002064 FA002011 FA002013 FA002014 FA002056 FA002065 FA002058
• Recalling Firm/ Manufacturer: Analogic Corporation; Centennial Industrial park; 8 Centennial Drive; Peabody MA 01960-7902
• For Additional Information Contact: Dean Smith; 978-326-43333
• Manufacturer Reason for Recall: Unit may not power up due to faulty circuit board
• FDA Determined Cause: Other
• Action: Analogic notified customers by letter dated 9/13/05. Distributors were requested to notify their accounts and return units for replacement of the main circuit board.
• Quantity in Commerce: 13 units
• Distribution: CT, PR Foreign: Algeria, Chile,Ecudor, Mexico, South Africa, Vietnam, Russia, United Arab Emirates, Phillipines, Singapore, Korea, Malyasia
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.